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Associate Director, Evidence Generation Biostatistics
2 months ago
Join a Legacy of Innovation 110 Years and Counting
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The position will manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget.
•The position may also collaborate with CROs (Clinical Research Organizations) and manage oversight.
•The position will partner with internal and external stakeholders to optimize Statistical methods, processes and standards.
•The position will have strong knowledge of major statistical methods within industry standards including proficiency on handling statistical software such as but not limited to SAS and R.
•The position will require proven skills in continuous improvement, project management, change management, and risk management.
•The position will act as main statistical contact for the assigned studies, in particular in cross-functional Study team(s).
Responsibilities
- Study Responsibility - Responsible, with limited supervision, for study activities assigned, e.g.
for a clinical study: provide input on the development of study protocol (design, sample size, statistical analysis strategy); Review CRF; Write SAP; Manage statistical analysis outputs with programming team; Ensure the interpretation of statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and execute additional statistical analyses required, including analyses of patient-reported outcomes (PROs) and Health Economic endpoints; Coordinate the statistical programmers involved in the development and execution of analyses; Provide guidance of the proper interpretation of statistical analysis results; Review or co-author the value dossier and scientific communications. Ensure timely, to budget and accurate completion of Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert in meeting or teleconferences with Health Authorities. Ensure compliance with international regulations. Ensure inspections readiness as well as prepare potential audits linked to assigned studies.
- Vendor Oversight Under limited supervision, responsible for providing direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines. Responsible, under supervision, for CRO selection from RFI (Request for Information) to contract agreement including, review and negotiation of base-line budget and timelines. Oversees budget management activities across the study duration.
- Operational Excellence and Innovation May lead and/or participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions. Maintains current knowledge of industry best practice in statistical methodology. May act as Subject Matter Expert for Statistics, by providing guidance and support to EG team members as well as representing EG department in cross-functional teams. Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards. Demonstrates leadership within Biostatistics by partnering with internal and external stakeholders to optimize Statistics technology, processes, and standards (improving quality/inspection readiness, decreasing cycle times, and reducing costs).
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- PhD in statistics, mathematics or related fields preferred
- Master's Degree in statistics, mathematics or related fields required
Experience Qualifications
- At least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting preferred
- 4 or More Years Experience in oncology Therapeutic Area and/or in late phase projects is preferred
Travel
Ability to travel up to 20% domestically and internationally.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
